Anticoagulant
COUMADIN® TABLETS
(Warfarin Sodium Tablets, USP) Crystalline
COUMADIN® FOR INJECTION
(Warfarin Sodium for Injection, USP)
DESCRIPTION
COUMADIN (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-( -acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its empirical formula is C19 H15 NaO4,and its structural formula may be represented by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.
COUMADIN Tablets for oral use also contain:
|
All strengths: |
Lactose, starch and magnesium stearate |
|
1 mg: |
D&C Red No. 6 Barium Lake |
|
2 mg: |
FD&C Blue No. 2 Aluminum Lake and FD&C Red No. 40 Aluminum Lake |
|
2-1/2 mg: |
D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake |
|
3 mg: |
FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C |
| |
Red No. 40 Aluminum Lake |
|
4 mg: |
FD&C Blue No. 1 Aluminum Lake |
|
5 mg: |
FD&C Yellow No. 6 Aluminum Lake |
|
6 mg: |
FD&C Yellow No. 6 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake |
|
7-1/2 mg: |
D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake |
|
10 mg: |
Dye Free |
COUMADIN for Injection is supplied as a sterile, lyophilized powder, which, after reconstitution with 2.7 mL sterile Water for Injection,contains:
|
Warfarin Sodium |
2 mg/mL |
|
Sodium Phosphate, Dibasic, Heptahydrate |
4.98 mg/mL |
|
Sodium Phosphate, Monobasic, Monohydrate |
0.194 mg/mL |
|
Sodium Chloride |
0.1 mg/mL |
|
Mannitol |
38.0 mg/mL |
|
Sodium Hydroxide, as needed for pH adjustment to |
8.1 to 8.3 |
|
